This webinar will give a good understanding of USP and FDA requirement and provide recommendations and tools for effective implementation.

Compendial methods such as USP and EP standards are validated by the organizations that have developed and published the method. The FDA requires users of such methods to demonstrate the user's competence to successfully run the method. For example, 21 CFR 211.194 (a) states: The suitability of all testing methods used shall be verified under actual conditions of use. However, the FDA does not give any further guidance on what, when and how. And the first revision of USP <1226> did not have specific recommendations. But FDA inspectors got out and write 483's and warning letters related to <1226>. Now USP has announced to come out with a new revision using the risk based approach for the type and extend of testing.

Reference material for easy implementation:
SOP: Verification of Compendial Methods
Checklist: - Verification of Compendial Methods
Case Studies; Verification of Compendial methods and Procedures
Areas Covered in the Session:
What are FDA and international requirements for compendial methods?
What and how much should be tested?
How to use the risk based approach?
Is system suitability testing enough?
Do all compendial routine methods require verification?
When could just system suitability testing be enough?
Should we verify all performance characteristics?
How much can we deviate from the compendial method without the need for a full revalidation?
What to do if the compendial procedure cannot be verified?
How frequently should compendial methods be re-verified?
What if our equipment was not included in the USP method validation experiments
Who Will Benefit:
Analysts
Lab Supervisors and Managers
QA managers and personnel
Analysts
Consultants
Teachers

Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00

webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

Phone: 800-447-9407
Fax: 302-288-6884